PREVENTION OF EARLY ASTHMA IN KIDS (PEAK)

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心机构，不一定为研究者机构。哮喘是儿科年龄组公共卫生面临的最重要挑战之一。不仅疾病的流行率在增加，特别是在学龄早期，而且儿童哮喘对卫生保健系统的经济负担也在增加。虽然有效的疗法可用于治疗哮喘，但这种治疗可以改变疾病的自然病程的证据有限。本研究的主要目的是确定早期吸入性抗炎药干预是否可以预防哮喘高危儿童随后发生显著的哮喘症状。该研究将比较吸入性氟替卡松（一种吸入性皮质类固醇）与安慰剂在2至4岁哮喘高危儿童中改变哮喘病程的效果。将有一个为期四周的磨合期，以确定儿童的资格和特点。儿童将被随机分配到两个治疗组中的一个;一个接受积极治疗，另一个接受安慰剂。这些儿童将接受为期24个月的连续治疗，然后是一年的观察期，以评估哮喘症状的模式。本研究有三个具体目标：1）评估在4岁或以下哮喘高危儿童中开始的吸入性皮质类固醇持续治疗是否可以预防4 - 6岁时发生严重哮喘，2）确定这种哮喘治疗是否可以预防与早发性哮喘相关的肺功能丧失和气道敏感性的发生，和3）评估可能与在生命早期长期使用吸入性类固醇相关的潜在副作用。如果这种治疗是有效的，它将改变我们在儿童早期管理哮喘的方式。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Asthma is one of the most important challenges to public health in the pediatric age group. Not only is the prevalence of the disease increasing, especially during the early school years, but the financial burden of childhood asthma on the health care system is also on the rise. Although effective therapy is available for the treatment of asthma, the evidence that such treatment can change the natural course of the disease is limited. The main purpose of this study is to determine if early intervention with inhaled anti-inflammatory agents in young children at high risk for the development of asthma may prevent the subsequent development of significant asthma symptoms. The study will compare the effects of inhaled fluticasone, an inhaled corticosteriod, to placebo in children 2 to 4 years of age at high risk of developing asthma, on altering the course of asthma. There will be a four-week run-in period to qualify and characterize children. Children will be randomized to one of two treatment groups; one receiving active treatment, the other placebo. The children will receive continuous treatment for a period of twenty-four months, followed by an observation period of one year that will assess the pattern of asthma symptoms. There are three specific objectives of this study: 1) To assess if continuous treatment with inhaled corticosteroids initiated in children 4 years or less at high risk of developing asthma can prevent the development of significant asthma at four to six years of age, 2) To determine if this asthma therapy can prevent both losses lung function and the development of airway sensitivity associated with early onset asthma, and 3) To assess potential side effects that may be associated with long term use of inhaled steroids in early life. If this treatment is effective, it will change the way we manage asthma in early childhood.